Comparison Study of MRI-Enema and Water Soluble Contrast Enema in the Assessment of Colorectal Anastomotic Integrity Prior to Stoma Reversal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The test accuracy of (1) water-soluble contrast enema (WCSE) for the detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment.
研究概览
简要总结
This protocol describes using an MRI-Enema technique to assess the integrity of colorectal anastomoses when compared to fluoroscopic water soluble contrast enema, and provides information the participant recruitment process, participant experience and study management.
详细描述
Both examinations will be performed ideally on the same day or a maximum of 7 days apart. The order of the two tests will be directed according to scan appointment availability. The WSCE will take place at St Marks Hospital London. Due to the MRI capacity at LNWH trust the MRI-Enema will take place at Number 9 Harley Street, London. A service level agreement will be in place for the scans to occur, and St Marks Seedcorn funding has already been awarded to fund the MRI scans. The patients will be asked to fill in a survey to assess their experience immediately after each test in each location.
MRI-Enema:
A 16Fr Foley catheter is introduced per-anus with the patient in a left lateral decubitus position on the MRI scanner table. If the anastomosis was low (within 5 cm of anorectal junction) the catheter will be taped to the skin to maintain its position. In the event of a mid-rectal or upper rectal anastomosis (>5 cm from anorectal junction), the catheter balloon may be filled with 2-5mls of water and withdrawn to a location at the top of the anal sphincter complex. In both instances, after catheter insertion the patient is then re-positioned to a supine body position.
The MRI protocol used is detailed below. In summary, T2 and T1 (with fat suppression) sequences are obtained prior to filling the lumen with contrast to assess the presence of any pre-sacral and peri-anastomotic fluid, to identify the presence of haematoma and to ensure the catheter is appropriately sited with the catheter tip above the anal canal and close to the anastomosis, ideally within 3cm.
The enema comprises a mixture of normal saline (400mls) and contrast agent (Gadovist, 4mls) to produce a 1% contrast solution which part fills a standard contrast enema bag and delivery system. The bag is attached to a fixed hook located 100cm above the scanner table height, such that fluid will deliver from the bag via the catheter according to gravity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of colonic / anterior resection with low pelvic anastomosis including: ileorectal anastomosis, ileal pouch-anal anastomosis, colorectal anastomosis.
- •Clinical requirement for assessment of anastomotic integrity (e.g. prior to reversal of defunctioning stoma)
- •Ambulatory Patient
- •Over 18 years of age
排除标准
- •History of gadolinium allergy
- •Contraindication to MRI
- •Known inability to tolerate MRI (e.g. claustrophobia)
- •Known inability to maintain anal continence
- •Unable or unwilling to consent
结局指标
主要结局
The test accuracy of (1) water-soluble contrast enema (WCSE) for the detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment.
时间窗: Up to 36 months
As above
The test accuracy of (2) MRI-Enema for detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment.
时间窗: Up to 36 months
As above
次要结局
- (2) Patient experience of WSCE vs MRI-Enema particularly relating to anxiety, comfort and embarrassment assessed on a non-validated five point questionnaire entitled 'MRI-Enema Study Patient Questionnaire v1.1'.(Up to 36 months)
- (1) The comparative sensitivity for reported outcome variables relevant to investigation of pelvic intestinal anastomotic integrity. Including but not limited to: collection, fistula, fibrosis, lymphadenopathy, stenosis.(Up to 36 months)